imipramine hydrochloride

Generic: imipramine hydrochloride

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name imipramine hydrochloride
Generic Name imipramine hydrochloride
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

imipramine hydrochloride 50 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-493
Product ID 72789-493_43f45733-f09e-ff01-e063-6294a90a07ad
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040903
Listing Expiration 2026-12-31
Marketing Start 2016-04-07

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72789493
Hyphenated Format 72789-493

Supplemental Identifiers

RxCUI
835568
UNII
BKE5Q1J60U

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name imipramine hydrochloride (source: ndc)
Generic Name imipramine hydrochloride (source: ndc)
Application Number ANDA040903 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-493-01)
  • 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-493-95)
source: ndc

Packages (2)

72789-493-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-493-01) 72789-493-95 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-493-95)

Ingredients (1)

imipramine hydrochloride (50 mg/1)

Linked Drug Pages (1)

Imipramine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "43f45733-f09e-ff01-e063-6294a90a07ad", "openfda": {"unii": ["BKE5Q1J60U"], "rxcui": ["835568"], "spl_set_id": ["7091ff32-55b9-48fd-a86d-c502af57473f"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-493-01)", "package_ndc": "72789-493-01", "marketing_start_date": "20250903"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-493-95)", "package_ndc": "72789-493-95", "marketing_start_date": "20250310"}], "brand_name": "Imipramine Hydrochloride", "product_id": "72789-493_43f45733-f09e-ff01-e063-6294a90a07ad", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "72789-493", "generic_name": "Imipramine Hydrochloride", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Imipramine Hydrochloride", "active_ingredients": [{"name": "IMIPRAMINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA040903", "marketing_category": "ANDA", "marketing_start_date": "20160407", "listing_expiration_date": "20261231"}